Phototherapy dressing for treating psoriasis

ABSTRACT

Methods and apparatuses for phototherapy to treat skin disorders. In particular, described herein are phototherapy dressings for use with phototherapy UV light applicators (sources) to treat skin disorders such as psoriasis. The dressings described herein may include a support body onto which a medicament formed of a hydrogel and coal tar and/or coal tar extract is held. The dressing may be configured so that at least half (50%) of the UV light within a therapeutic range of wavelengths is through the dressing including the medicament to the patient&#39;s skin. The dressings may be adapted for use in conjunction with a phototherapy UV light sources.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/187,614, filed Jun. 20, 2016, titled “PHOTOTHERAPY DRESSING FORTREATING PSORIASIS,” now U.S. Pat. No. 10,058,711, which is acontinuation of U.S. patent application Ser. No. 14/632,161, filed Feb.26, 2015, titled “PHOTOTHERAPY DRESSING FOR TREATING PSORIASIS,” nowU.S. Pat. No. 9,370,449, which claims priority to U.S. ProvisionalPatent Application No. 61/944,755, filed on Feb. 26, 2014, titled “SAFETHERAPEUTIC LIGHT SYSTEM” and U.S. Provisional Patent Application No.62/049,366, filed Sep. 12, 2014, titled “THERAPEUTIC LIGHT SYSTEM,” eachof which is herein incorporated by reference in its entirety.

INCORPORATION BY REFERENCE

All publications and patent applications mentioned in this specificationare herein incorporated by reference in their entirety to the sameextent as if each individual publication or patent application wasspecifically and individually indicated to be incorporated by reference.

FIELD

Described herein are phototherapy methods and apparatuses, andspecifically phototherapy methods, dressings, and UV light applicatorsfor treating disorders, including phototherapy methods, dressings andapplicators for treating psoriasis that are safe and easy to use by apatient at home.

BACKGROUND

Light, when delivered to the body, has been shown to elicit a wide rangeof therapeutic effects. Specifically, light can be used as a therapeuticagent for various disorders. Light, in the Ultraviolet (UV) spectrum,may be used as a treatment for skin disorders such as psoriasis,vitiligo, dermatitis, asteatotic, purigo, pruritis, etc. Light therapyis often delivered in a doctor's office or at home in chambers thatdeliver light to the entire body surface or with smaller light sourcesfor delivery of light to focused areas of the body. Typically, a trainedprofessional is required to deliver the light to ensure that the patientreceives the correct dose of light and that sensitive areas, such as theeyes, are not exposed to the light.

In a light chamber, the amount of light delivered is based on the amountof time the patient is exposed to light. The light is delivered to theentire body even though the region that requires treatment oftencomposes a fraction of the overall surface area of the body. Whenreceiving this modality of light therapy, the patient must wearprotective eyewear to prevent exposure of light to the eyes. If thepatient is exposed to more light than intended, cellular damage and/orburns may occur over a large portion of the body, leading to significantdiscomfort and even medical treatment.

Using a focused light solves the issue of light exposure to areas thatdo not need therapy because the user directs the light to the area wherethe therapy is needed. When therapy is delivered at home and the usercontrols where the light is being delivered, there is increased risk ofoverexposure of one area of the body and underexposure of another area.In addition, the light can be inadvertently directed towards sensitiveareas such as the eyes or genitals.

Further, there is evidence to show that light therapy treatment for skindisorders has been limited by patient's unwillingness to receivetreatment in doctor's offices and lack of adherence to home lighttherapy systems. Adherence to therapy at home may be improved byincreasing patient engagement and improving device ease of use.

Light therapy may also be combined with topical treatments. For example,coal tar is used as a therapeutic in conjunction with (though typicallynot at the same time) as phototherapy. For example, phototherapy withUVB has been used with coal tar (the Goeckerman regimen) as well as withanthralin. The Goeckerman regimen uses daily treatments for up to 4weeks. The coal tar or anthralin is applied once or twice each day andthen washed off before the procedure. Studies indicate that a low-dose(e.g., 1%) coal tar preparation is as effective as a high-dose (6%)preparation. Such regimens are unpleasant, but are still useful for somepatients with severe psoriasis, because they can achieve long-termremission (up to 6-12 months). Treatments involving both UVB and coaltar or other topical drugs typically involve the separate application ofthe UVB and coal tar, in part because it coal tar is messy, odiferousand blocks or absorbs much of the delivered UV light. For this reason,coal tar is often applied after administration of the UVB.Unfortunately, bifurcating treatment in this way complicates thetreatment, and may further limit the effectiveness. In addition, the useof a topical agent such as coal tar may be messy and unpleasant, atleast in part because of the odor associated with the agent and the useof oil-based agents (e.g., petroleum) solubilizing the coal tar (or coaltar extract).

Thus, there is a need for apparatuses and methods for phototherapy,particularly for the treatment of skin disorders such as psoriasis, thatare easy to use in even a home environment, and otherwise permit theapplication of therapeutic light to one or more specific areas of apatient's skin. The apparatuses and methods described herein may addressthese concerns.

SUMMARY

In general, described herein are methods and apparatuses (includingdevices and systems) that may be used to deliver phototherapy. Inparticular, described herein are phototherapy dressings, phototherapy UVlight applicators (sources), and methods of using them to treat skindisorders such as psoriasis. The dressings described herein aregenerally adapted for use in conjunction with the phototherapy UV lightsources; the dressing may be adapted to include one or more connectors(mechanical, magnetic/electromagnetic, etc.) for connecting with a UVlight source. The UV light source may also or alternatively have aconnector for connecting to the dressing, which may be complimentary toa corresponding connector or connector region on the dressing. Theconnector(s) may be oriented and/or configured so that the connection isoriented. In addition, the phototherapy dressings and phototherapy UVlight sources described herein may also be configured to exchangeinformation. For example, the dressing may include a unique identifierthat can be read by the phototherapy UV light source and/or by a userdevice such as a hand-held computing device (e.g., smartphone, pad,etc.), which may also communicate with the UV light source. The uniqueidentifier may include information specifically identifying the dressing(e.g., a model, make, batch, lot number, etc.) and this information maybe associated with use information (e.g., number of phototherapy dosesapplied through the dressing, location of the dressing on the patient'sskin, expiration date of the phototherapy dressing, etc.).

In general, the phototherapy dressings described herein include amedicament that is held against the patient's skin when the dressing isworn by the patient. The medicament may be a semisolid substance havinga viscosity greater than water including and a drug or agent suspendedin the semisolid substance. In particular, the semisolid substance maybe a hydrogel and the drug or agent may be coal tar, e.g., coal tar orcoal tar extract between about 0.1% and 5.0% in the hydrogel. Althoughthese phototherapy dressings (which may be referred to herein as simply“dressings” or UV light dressings) may be particularly well suited foruse with the phototherapy UV light applicators described herein, theymay also or alternatively be used by themselves (e.g., to deliver themedicament) or with another device (e.g., thermal applicator devices, RFapplicator devices, etc.).

In general, the dressings described herein are configured specificallyso that they block only a fraction of UV light within a therapeuticrange (e.g., 295 to 320 nm, or any sub-region within this range),allowing UV light to be applied through the dressing onto the skin,while simultaneously applying the drug or agent (e.g., coal tar or coaltar extract) to the skin in a dressing that has a low moisture vaportransmission. Thus, the dressing may be configured so that themedicament (e.g., hydrogel and coal tar/coal tar extract) and thedressing (e.g., the region of the body of the dressing covering themedicament) permit more than a predetermined percentage of the UV lightin the target frequency range to pass through the dressing and onto theskin beneath the dressing. The predetermined percentage of UV light mayrefer to any appropriate predetermined percentage, which may be selectedbased on the dosage and treatment time. For example, the predeterminedpercentage may be greater than 20%, greater than 25%, greater than 30%,greater than 35%, greater than 40%, greater than 45%, greater than 50%,greater than 55%, greater than 60%, greater than 65%, greater than 70%,greater than 75%, greater than 80%, greater than 85%, greater than 90%,or greater than 95%, etc. This may be expressed conversely, so that thedressing (or at least a treatment region of the dressing, e.g., formingan island region within the middle portion of the dressing) occludesless than 5%, less than 10%, less than 15%, less than 20%, less than25%, less than 30%, less than 35%, less than 40%, less than 45%, lessthan 50%, less than 55%, less than 60%, less than 65%, less than 70%,less than 75%, less than 80%, etc.

The dressing may be configured to pass UV light through the dressing fordelivery to the subject's skin based on the material selected, such asthe material forming the support body of the dressing as well as thematerial forming the medicament, as well as the dimensions (andparticularly the thickness, e.g., in a direction normal to the skin whenworn) and surface interfaces (e.g., textures) of these material. Forexample, the material forming the portion of the support body over themedicament may be a polymeric material with a relatively hightransmission of UV light in the therapeutic frequency range desired. Forexample, relatively thin layers of polyurethane materials or polyestermaterial, e.g., between about 0.001 to 0.005 inches thick. Themedicament may generally include a high-water content semisolid material(such as a hydrogel) mixed with between about 0.1 and 5% coal tar and/orcoal tar extract. The hydrogel may have a water content of between about90 and about 99.5% water. The medicament may be coated or layered ontothe support body and may also be relatively thin (e.g., having athickness of between about 0.005 and about 0.1 inches (e.g., betweenabout 0.01 inches to about 0.08 inches thick, e.g., between about 0.02and about 0.05 inches thick, etc.). Surprisingly, the Applicants havefound that that coal tar and coal tar extract do not require the use ofan oil-based (e.g., petroleum) medium to suspend the material, but thata hydrogel will work, permitting UV transmission. In contrast, oil-basedmaterials may occlude most of the UV light (e.g., greater than 90% evenin very thin layers). Any appropriate hydrogel may be used, for example,hydrogels that are hydrophilic and primarily composed of water (e.g.,deionized water, aloe vera gel, glycerine, sorbitol, carbomer 940,triethanolamine, allantoin, disodium EDTA, methylparaben, andimidazolidinyl urea), or the like. In one example, this hydrogel may bemixed with 2% coal tar (or 5% coal tar extract), and applied as a layerapproximately 0.03 inches thick to a support body formed of polyurethanethat is approximately 0.002 inches thick with a roughened surface tohelp adhere the medicament (hydrogel and coal tar/coal tar extract);this configuration will permit greater than half (50%) of the UV lightat wavelengths between 300 and 320 to pass through the entire dressing.In some variations, coal tar extract (e.g., “Neutar”) is purified, andmay be used at a higher percent than coal tar relative to the occlusionof comparable levels of UV light. In addition to enhancing the UVtransparency of the dressing, mixing the coal tar with a hydrogel (thatmay be substantially free of alcohol and/or oils typically used todilute coal tar or coal tar extract) for topical use in a dressing mayalso significantly increases the efficacy of the tar. In particular, thedressings described herein may provide a moisture barrier that may bothreduce the unpleasant odors of the coal tar/coal tar extract, and mayimprove efficacy.

In general a phototherapy dressing may include: a support body; amedicament in communication with the support body, the medicamentincluding a semisolid substance having a viscosity greater than waterincluding between about 0.1% and 5.0% coal tar or car tar extract;

and an attachment for a phototherapy UV light source on the supportbody, wherein the attachment is configured to secure the phototherapy UVlight source over the phototherapy dressing; wherein more than half ofUV light emitted by the phototherapy UV light source at wavelengthsbetween 300 and 320 nm passes through the phototherapy dressing,including the through the medicament.

For example, described herein are phototherapy dressings for skindisorders such as psoriasis. A phototherapy dressing may include: asupport body having an island region; a medicament in communication withthe island region, the medicament including a hydrogel including betweenabout 0.1% and 5% coal tar or coal tar extract; wherein the medicamentand island region together occlude less than 50% of UV light atwavelengths between 300 and 320 nm from passing through the phototherapydressing; and a magnetic attachment for a phototherapy UV light sourceon the support body, the magnetic attachment configured to secure thephototherapy UV light source over the island region of the phototherapydressing.

Any of the phototherapy dressings described herein may be phototherapydressings for treating psoriasis and may include: a support body; amedicament in communication with the support body, the medicamentincluding a hydrogel including between about 0.1% and 5% coal tar orcoal tar extract; wherein the medicament and support body togetherocclude less than 50% of UV light at wavelengths between 300 and 320 nmfrom passing through the phototherapy dressing; an adhesive on thephototherapy dressing; and a magnetic attachment for a phototherapy UVlight source on the support body, the magnetic attachment configured tosecure the phototherapy UV light source to the phototherapy dressing.

As mentioned, the semisolid substance of the medicament may be ahydrogel. Any appropriate hydrogel may be used, particularly those thatare substantially alcohol and oil (e.g., petroleum) free, e.g., havingless than 0.1%, less than 0.05%, less than 0.01%, less than 0.005%, lessthan 0.001% of alcohol and/or oil, etc.). The semisolid (e.g., hydrogel)material may have a high water content (e.g., >90%, greater than 91%,greater than 92%, greater than 93%, greater than 94%, greater than 95%,greater than 96%, greater than 97%, greater than 98%, greater than 99%,99.5% or more, etc. of water), and may include the coal tar (e.g.,between about 0.01% and 10%, 0.01% and 7%, 0.1% and 8%, 0.1% and 7%,0.1% and 6%, 0.1% and 5%, 0.1% and 4%, 0.1% and 3%, 0.1% and 2%, 0.1%and 1%, or any sub-region thereof) or coal tar extract (e.g., betweenabout 0.01% and 10%, 0.01% and 7%, 0.1% and 8%, 0.1% and 7%, 0.1% and6%, 0.1% and 5%, 0.1% and 4%, 0.1% and 3%, 0.1% and 2%, 0.1% and 1%, orany sub-region thereof).

Any of the phototherapy dressings described herein may include anadhesive (e.g., a biocompatible adhesive) on the phototherapy dressing,e.g., peripheral to the island region. In some variations the semisolidmedicament material (e.g., hydrogel) may be sufficiently adhesive tosecure the dressing to the skin, and an additional adhesive is notnecessary. However, it may be desirable to include an adhesive,particularly around the periphery of the medicament in the dressing sothat the dressing acts as a vapor barrier over the treatment region ofthe skin.

For example, any of the phototherapy dressings described herein may beconfigured to have moisture vapor transmission rate (MVTR) of less than2.3 g/m²/h (grams/meter²/hour). 2.3 g/m²/h typically corresponds to theminimum moisture transmission rate of the skin; thus at this rate, thebandage will maintain or increase the moisture content of the skin overthe treatment region. Although the support body in this region may allowwater vapor to pass (although it may be treated to limit vapor passagein some variations), the proximity to the hydrogel may maintain thismoist region against the skin with minimal loss of moisture from thehydrogel as a whole. Thus, in any of these variations, the dressing mayact as a moisture vapor barrier.

As mentioned, the support boy may be a polymeric material arranged in alayer to be worn against the patient's skin. The layer may be relativelythin (e.g., less than 0.01 inches thick) and may be formed of apolymeric material. For example, the support body may comprise a thinlayer of polyurethane or polyester, or any other material that permitsthe transmission of UV light (e.g., greater than 50%, 60%, 70%, 80%, 90%of the UV light in the therapeutic frequency range).

In general, the therapeutic UV light wavelength (or conversely,frequency) range may be between 295 and 330 nm, e.g., between 295 and320 nm, between 295 and 306 nm, between 295 and 304 nm, between 295 and302 nm, between 295 and 300 nm, between 300 and 330 nm, between 300 and320 nm, between 300 and 315 nm, between 300 and 311 nm, between 300 and306 nm, between 300 and 303 nm, between 303 and 320 nm, between 303 and318 nm, between 303 and 316 nm, between 303 and 311 nm, between 303 and306 nm, between 305 and 330 nm, between 305 and 320 nm, between 305 and316 nm, between 305 and 309 nm, between 310 and 330 nm, between 310 and320 nm, between 310 and 316 nm, between 315 and 330 nm, between 315 and325 nm, between 315 and 320 nm, or any sub-region of these).

Overall, the phototherapy dressing may be relatively thin, e.g., havinga thickness of less than 0.2 inches, 0.1 inches, 0.09 inches, 0.08inches, 0.07 inches, 0.06 inches, 0.05 inches, etc., particularly overthe treatment region. The dressing may be thicker in some regions thanothers, e.g., in the connector region configured to couple to the UVlight source. In some variations the dressing includes a rim, lip,channel, ridge, etc. around the region that mates with the UV lightsource. This rim or lip region may prevent light from escaping when UVlight is applied by the UV light source.

In general, the phototherapy dressing may have a low thermalconductivity. For example, the thermal conductivity of the dressing maybe less than 0.32 W/m/′ C.

As mentioned above, any of the phototherapy dressings described hereinmay include one or more identifiers (e.g., unique or semi-unique)identifiers that allow another device to identify the dressing andassociate a particular dressing with information specific to the use ofthe dressing, including the composition of the dressing, the model/makeof the dressing, the position of the dressing on the patient, the numberof times the dressing has been treated with UV light, etc. Theidentifier (which may be referred to as a unique identifier) may belocated on the support body and may be associated with a particularphototherapy dressing. The identifier may be a code such as a printedbar code, QR code, alphanumeric code, etc. that can be scanned or readby another device (e.g., a mobile, hand-held device and/or the UV lightsource). The identifier may be an RFID identifier or otherelectromagnetic signature/identifier. In some variations the identifiermay be a chip that can transmit and/or receive information about itsidentity and/or operation. Thus, an identifier may be one or more of: anRFID tag, an optical code, a magnetic signature, or an alphanumericcode.

As mentioned, in any of the phototherapy dressings described herein, thedressing may include an attachment configured to releasably couple witha phototherapy UV source. For example, the attachment may be amechanical attachment (e.g., snap, Velcro/hook and loop, clip, tie,strap, screw, button, hook, etc.) or a magnetic/electromagneticattachment (e.g., permanent magnet, electromagnet, etc.). In somevariations the attachment includes a plurality of magnets on the supportbody; the magnets may be positioned off-center of the dressing, e.g.,around the periphery of the dressing.

Also described herein are methods of treating a skin disorder by UVphototherapy. In particular, methods of treatment include methods oftreating a skin disorder such as psoriasis. Treatment methods typicallyinclude applying one or more of the dressings described above (having amedicament such as hydrogel and coal tar and/or coal tar extract) on theskin in the desired treatment sites, and applying one or more treatmentdoses of UV light. The treatment dose may be calculated (as describedbelow), but may be applied for between 1 second and 20 minutes (e.g.,between 1 second and 15 min, between 1 second and 12 min, between 1 secand 10 min, between 1 min and 20 min, between 1 min and 15 min, between1 min and 12 min, between 1 min and 10 min, etc.). The treatment doesmay be determined based on patient feedback (e.g., skin sensitivity) aswell as characteristics of the dressing (e.g., how much UV willpenetrate to skin, size of the treatment area, etc.) and characteristicsof the UV source (e.g., how much energy the device will or is capable ofdelivering). Although any appropriate UV source may be used, example UVsources are provided herein.

For example, a method of treating psoriasis by UV phototherapy mayinclude: attaching a dressing to a patient's skin, wherein the dressingcomprises a medicament, the medicament including a hydrogel includingbetween about 0.1% and 5.0% coal tar or car tar extract; coupling aphototherapy UV light source to the dressing; and applying UV lightthrough the dressing from the phototherapy UV light source, includingthrough the medicament, wherein more than half of UV light emitted bythe phototherapy UV light source between 300 and 320 nm passes throughthe dressing.

A method of treating psoriasis by UV phototherapy may include: attachinga dressing to a patient's skin, wherein the dressing comprises amedicament, the medicament including a hydrogel including between about0.1% and 5.0% coal tar or car tar extract; magnetically coupling aphototherapy UV light source to the dressing; detecting a uniqueidentifier on the dressing using a hand-held device; calculating, usingthe hand-held device, a treatment dose of UV light; and applying thetreatment dose by applying UV light through the dressing from thephototherapy UV light source, including through the medicament, whereinmore than half of UV light emitted by the phototherapy UV light sourcebetween 300 and 320 nm passes through the dressing.

Any of these methods may include detecting a unique identifier on thedressing using a hand-held device. The hand-held device (e.g.,smartphone, iPad, etc.) generally includes a processor and may beconfigured to run control logic that causes the processor to calculatetreatment dosing and/or communicate (e.g., dosing information) to thephototherapy UV light source. In some variations the UF light sourceitself includes a processor and is capable of receiving the identifier.

In variations including a processor (e.g., in a hand-held device), theprocessor may be configured by control logic to calculate, using thehand-held device, a treatment dose of UV light.

As mentioned above, in any of the methods, the UV light source may beattached to the phototherapy dressing. For example, the phototherapy UVlight source may be magnetically coupled to the periphery of thetreatment region on the dressing. For example, applying UV light mayinclude automatically applying a calculated treatment dose of UV light.

Any of the methods described herein may also include confirming couplingof the phototherapy UV light source to the dressing prior to applying UVlight. For example the UV light source may sense or detect theattachment/coupling by a magnetic coupler.

The treatment dose may be calculated by the UV light source or by ahand-held device with a processor (e.g., smartphone), For example, atreatment dose may be calculated based on the skin type of the patient,a number of previous doses applied to the dressing, and the patient'sskin sensitivity. Calculating the treatment dose of UV light may includecalculating the treatment dose based on the skin type of the patient, anumber of previous doses applied to the dressing, and the patient's skinsensitivity.

In general, the methods described herein typically include delivering aplurality of doses per day. These doses may be manually or automaticallyy applied, and (as mentioned earlier) the method may include applying UVlight therapy through different dressings. In general, a dressing mayalso be referred to as a bandage, wrap, compress, poultice, plaster,cover, etc.

Any of these methods may include delivering one or more doses todifferent dressings on the body. For example, a method may includeapplying UV light through a second dressing on the patient's skin todeliver a second treatment dose. In some variations the delivery tomultiple dressings may be used to determine dosing information, e.g., byvarying the treatment does from the second treatment (compared to afirst treatment dose in a different location) dose to determine aminimal erythemal dose (MED).

Also described herein are phototherapy UV light sources and systemsincluding phototherapy UV light sources and/or phototherapy dressings,as described briefly above. The phototherapy UV light source and thephototherapy dressing may be configured (e.g., with complimentaryconnectors) to couple together. In general, the UV light sourcesdescribed herein include a one or more LEDs or other sources of UVlight. For example, the phototherapy UV light source described hereinmay include a plurality of UV emitting LEDs (e.g., 18 LEDs arranged in a3×6 array within a 2 inch by 1 inch rectangle).

For example, a system for treating skin disorders by UV phototherapy,may include: a phototherapy dressing comprising a support body, and amedicament in communication with body, the medicament including ahydrogel having between about 0.1% and 5% coal tar or car tar extract,wherein the body and medicament occlude less than 50% of UV light atwavelengths between 300 and 320 nm from passing through the phototherapydressing; and a phototherapy UV light source configured to emit UV lightat an intensity of greater than 2 mW/cm² at a wavelength between 300 and320 nm, and a connector configured to magnetically secure thephototherapy UV light source to the phototherapy dressing.

A system for treating skin disorders by UV phototherapy may include: aphototherapy dressing comprising a support body, and a medicament incommunication with body, the medicament including a hydrogel havingbetween about 0.1% and 5% coal tar or car tar extract, wherein the bodyand medicament occlude less than 50% of UV light at wavelengths between300 and 320 nm from passing through the phototherapy dressing; aphototherapy UV light source configured to emit UV light at an intensityof greater than 2 mW/cm² at a wavelength between 300 and 320 nm, and aconnector configured to secure the phototherapy UV light source to thephototherapy dressing; and control logic configured to determine atreatment dose, wherein the control logic is configured to controlapplication of the treatment dose by the UV light source.

As mentioned any of these systems may include control logic configuredto determine a treatment dose, wherein the control logic is furtherconfigured to control application of the treatment dose by the UV lightsource. The control logic may generally be a non-transient computerreadable storage medium that controls the operation of the processor onwhich it is operating to regulate and monitor the processor and device(e.g., phone), including to calculate therapeutic dose.

Any of the systems described herein may include a safety circuitconfigured to prevent the phototherapy UV light source from emitting UVlight unless the phototherapy UV light source is coupled to thephototherapy dressing. The phototherapy UV light sources may alsogenerally include an extension or skirt region around the light-emittingportion, to prevent spill-over of UV light when it is being applied to apatient's lesion.

As mentioned, the phototherapy dressing may include one or more magneticcouplers configured to couple with the connector of the phototherapy UVlight source. In addition, the phototherapy UV light source may includea thermistor, and the phototherapy UV light source nay be configured tolimit the delivery of UV light based on the thermistor.

The control logic referenced above may determine treatment dose based onone or more of: a type of disease, a skin type, a patient feedback onskin sensitivity, a previous dose history, an amount of UV lightabsorbed by the dressing, an edge detection for recognition and guidanceof the UV light, an amount of induration, an amount of scale, an amountof redness, a location of the lesion, and a thickness of epidermis. Thecontrol logic may be configured to determine the treatment dose based ona center of the wavelengths emitted by the UV light source. For example,the light wavelength claimed as the therapeutically relevant range maybe centered at less than 306 nm (e.g., less than 305 nm, less than 304nm, less than 303 nm, less than 302, etc.) and has a full width halfpower of less than 30 nm, 25 nm, 20 nm, 18 nm, 15 nm, etc. In somevariations, the starting treatment dose is less than 132 mj/cm².

Although the dressings above (and descried herein) may include a supportbody (which may include attachment sites for the UV light source), insome variations the apparatus includes just the hydrogel, which may beapplied the body directly. For example, described herein are hydrogelsthat may be mixed with a therapeutic (e.g., coal tar, coal tar extract)and applied to the skin.

For example a hydrogel (which may be used with a phototherapy procedure)may include: water in a concentration between 90 and 99.9%; and coal taror coal tar extract between 0.1 and 5% by weight/volume; wherein thehydrogel occludes less than 50% of UV light at wavelengths between 300and 320 nm.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-1B illustrate one embodiment of a dressing that may be usedwith a phototherapy system.

FIG. 1C illustrates one variation of a hydrogel that may that may beused with a phototherapy system as described herein.

FIGS. 2A-2D illustrate four embodiments of unique identifiers of adressing.

FIGS. 3A-3C illustrate three embodiments of a system for treating skindisorders by ultraviolet phototherapy.

FIGS. 4A-4C illustrate two embodiments of a dressing with connectors foralignment with a light source.

FIG. 5 illustrates one embodiment of a system with a shutdown circuit.

FIG. 6 illustrates a method for determining a therapeutic dose of light.

FIG. 7 illustrates a location indexing system for a person's hand(s)and/or feet.

FIG. 8 illustrates a method for treating psoriasis by UV phototherapy.

Figures may are not shown to scale unless otherwise indicated.

DETAILED DESCRIPTION

The following description of the preferred embodiments is not intendedto limit the invention to these preferred embodiments, but rather toenable any person skilled in the art to make and use this invention.

Phototherapy apparatuses (including systems and devices), and relatedmethods are provided herein, including, but not limited to: phototherapydressings for concurrent delivery of a medicament (e.g., coal tar and/orcoal tar extract in a hydrogel); medicaments including a hydrogel andcoal tar and/or coal tar extract that may be used alone or with adressing; phototherapy UV light sources capable of operating with thephototherapy dressings and/or medicament; control logic for determiningtherapeutic dosing and/or controlling the phototherapy UV light source;and methods of using any of these. In general, these apparatuses andmethods may be used to deliver therapeutic energy to a person. Althoughthe majority of examples provided herein are for the delivery of lightenergy, e.g., UV (including narrow band UV) light, the methods andapparatuses described herein may also be used with other energymodalities, including other electromagnetic radiation waves, such asinfrared light, blue light, radiofrequency waves, and magnetic energy,as well as non-electromagnetic energy such as ultrasound, or any othertype of therapeutic energy. For example, the methods and apparatusesdescribed herein may be used to apply therapeutic ultrasound may be usedto treat ligament sprains, muscle strains, bursitis, tendonitis, jointinflammation, plantar fasciitis, metatarsalgia, facet irritation,impingement syndrome, rheumatoid arthritis, osteoarthritis, teeth, bone,myofascial pain, and/or scar tissue adhesion. Radiofrequency therapy maybe used to treat tumors, cardiac arrhythmias, chronic and post-operativepain, bone fractures, and soft tissue wounds.

Therapeutic UV light may be used to treat a skin disorder or disease.For example, psoriasis, eczema, vitiligo, acne vulgaris, neonataljaundice, atopic dermatitis, acute forms of dermatitis, lichen planus,or any other skin disorder or disease may be treated by the systems andmethods disclosed herein. Alternatively or additionally, therapeutic UVlight may be used to treat depression, jaundice, seasonal affectivedisorder, fibromyalgia, patients that are phase delayed, cancer(photopheresis), chronic ulcers, rheumatoid arthritis, osteoarthritis,tendinopathy, chronic joint disorders, and periodontitis. In particular,described herein are methods and apparatuses for treating skin disorderssuch as psoriasis.

A patient (e.g., a person or subject) and/or clinician (doctor, nurse,assistant, medical technician, etc.) may use the systems and methodsdescribed herein at home, in a clinic, in a hospital, in a vehicle, orin any other location.

Dressing

The medicaments described herein may be specifically formulated for theapplication of energy (such as UV energy) concurrent with the deliveryof a topical therapeutic agent (e.g., coal tar, coal tar extract, etc.).In particular, the medicament may be configured so that it is largelytransparent to the to the applied energy modality. For example, amedicament for use with the delivery of UV energy may include asemisolid substance (e.g., a suspension, a colloid, etc.) into which themedicament has been added at an appropriate therapeutic level. Themedicament may include, for example, a hydrogel (having a high watercontent, e.g., between 90 and 99.9% water), and a medicament such ascoal tar and/or coal tar extract (e.g., between 0.1 and 5% byweight/volume). The medicament may be configured to occlude less than atarget percent of the UV light transmitted through it (e.g., whenapplied to a skin surface, including as part of a dressing). The amountof UV transmission through the medicament may be controlled bycontrolling the composition (e.g., percentage of coal tar and/or coaltar extract, typically between 0.1% and 10%, more preferably between0.1% and 5%), thickness (e.g., between about 0.01 inches to 0.1 inchesthick, e.g., between about 0.01 inches and about 0.08 inches thick,etc.). When applied as part of a dressing, the medicament may be appliedonto a surface of the dressing, such as a thin support or support body,so that a portion of the dressing (support body) partially covers oneside of the medicament; the other side may contact the patient's skin.In some variations the dressing may include an opening so that thesupport body does not cover the medicament, and therefor doesn't occludethe UV light transmission in this region. In variations in which thesupport body of the dressing is in the path of the UV light (e.g.,between the UV light source and the skin) in addition to the medicament,this portion of the dressing may be relatively UV light transparent inthe therapeutic frequency of UV light to be applied, so that the totalUV light transparency through the dressing including the medicament isgreater than a predetermined minimum threshold, such as 20%, 30%, 40%,50%, 60%, 70%, 80%, 90%, etc. For example, to deliver a dose of UVenergy within the therapeutic range of about 295-330 nm (e.g., 300-320nm or any other sub-range within 295-330 nm) over a reasonable amount oftime using a phototherapy UV light source, including those describedherein, the minimum percentage of UV light transmitted through thedressing (including any intervening support body of the dressing surfaceand the medicament) may be about 40% (or about 45%, about 50%, about55%, etc.) where each therapeutic does last for between about 1 minuteand 20 minutes (e.g., 5 min-15 min, 10 min-20 min, etc.). For example,when the dressing includes a medicament comprising a hydrogel andbetween about 0.1 and 5% coal tar or coal tar extract, and themedicament is about 0.01 inches to 0.08 inches thick (where thickness isthe direction normal to the skin), and the dressing also includes a thinsupport layer (support body) formed of a polymeric material (e.g.,polyurethane) that is less than 0.005 inches thick, the dressing mayoccludes less than 50% of UV light at wavelengths between 300 and 320nm.

FIGS. 1A and 1B illustrate one embodiment of a dressing 2 for use with aphototherapy system. This dressing 2 may be used to treat a conditionsuch as a skin disorder (e.g., skin disease, etc.). The dressing may beused in concert with a therapeutic energy-delivering device as describedbelow, but it may also be used independently for therapy, including forwound healing, skin treatment, or any suitable applications, clinical orotherwise. A dressing 2 for use with a phototherapy procedure mayinclude a body 4, a medicament 6, and an adhesive 8.

In one embodiment, a dressing for use with a phototherapy systemincludes a body 4, as shown in FIGS. 1A and 1B that is flexible andplanar. The shape of the body may thin, particularly over the medicament6, though it may be thicker in other regions. For example, the region ofthe support body over the medicament may be less than 0.009 inches thick(e.g., less than 0.008 inches, less than 0.007 inches, less than 0.006inches, less than 0.005 inches, less than 0.004 inches, less than 0.003inches, less than 0.002 inches thick, etc.). In some embodiments, thedressing includes a medicament as described above, such as a hydrogel, alow or high durometer silicone, urethane, other flexible polymers, ahydrocolloid, or a combination of one or more of these materials. Themedicament may be attached to the body of the dressing, or separatelyapplied to the skin so that the dressing may be applied over it. Whenthe medicament is attached, the medicament for UV phototherapy mayinclude a hydrogel and a therapeutic agent such as (but not limited to)coal tar (and/or coal tar extract) at a therapeutic concentration (suchas between about 0.1% and 10%, e.g., 0.1% and 5%, etc.). As mentioned,the dressing, including the body and the medicament, may be configuredto occlude less than a predetermined amount (e.g., 50%) of UV light atwavelengths within a therapeutic range (e.g., between about 300 and 320nm). For example, the dressing may occlude less than 40%, 30%, 20%, 10%,or 1% of UV light at wavelengths between 300 and 320 nm. In oneembodiment, the dressing occludes no (i.e., 0%) or approximately no UVlight. In some embodiments, the dressing may occlude less than 50% of UVlight at wavelengths between 250 and 400 nm or any sub-range therebetween; for example, the dressing may occlude less than 50% of UV lightat wavelengths between 250 and 300 nm, 300 and 350 nm, or 350 and 400nm.

In FIGS. 1A and 1B, a dressing 2 that may be used with a phototherapysystem includes a medicament 6. The medicament may decrease dryness,decrease skin scaling, increase dead skin cell shedding, decreaseitchiness, and/or increase/decrease any other property of the skin orunderlying tissues. In general, the medicament may include apharmaceutical agent (therapeutic agent); in some embodiments, themedicament may comprise a homeopathic or non-medicated therapy or salve.A medicament may include, for example, an agent such as a hormone, anantibiotic, an antimicrobial, an antifungal, an anesthetic, anantiseptic, an anti-inflammatory, antihistamine, an analgesic, an acnemedication, an anti-aging compound, a moisturizer, a hair growthpromoter, a hair growth preventer, a skin growth promoter, a cleanser,or any other beneficial substance. In some embodiments, the medicamentmay include coal tar, coal tar extract, corticosteroids, salicylic acid,anthralin (dithranol), cade oil, vitamin D analogues (e.g.,calcipotriene, anthralin, tazarotene, calcitriol), steroids, psoralen,aloe vera, jojoba, zinc pyrithione, capsaicin, acetic acid, urea,phenol, or any other medicament known to one skilled in the art to betherapeutic or helpful for topical treatment (and particularly topicaltreatment in conjunction with a phototherapy or other energy-applicationtherapy). Even agents, such as coal tar and/or coal tar extract that areknown to significantly occlude UV light may be incorporated into aphototherapy medicament and/or dressing; as described herein, suchactive agents may be prepared as described herein so that the resultingdressing with medicament does not significantly occlude therapeuticlight (e.g., occludes less than 50%, 40%, 30%, 20%, 10%, or 1%).

As described above, of particularly interest for UV phototherapyapplications, a medicament may include a hydrogel and coal tar and/orcoal tar extract. For example, the medicament may include between about0.01% and 10% coal tar or coal tar extract.

Alternatively, the medicament may include between about 0.001% and0.01%, 0.01% and 0.1%, 0.1% and 0.5%, 0.5% and 1%, 1% and 1.1%, or anyother percentage. In some embodiments, the medicament may absorb lessthan 40%, 30%, 20%, 10%, or 1% UV light at wavelengths between 300 and320 nm. In some embodiments, the medicament absorbs no or substantiallyno UV light at wavelengths between 300 and 320 nm. In one embodiment,the medicament absorbs less than 50% of UV light at wavelengths between300 and 320 nm. In some embodiments, the medicament may absorb less than40%, 30%, 20%, 10%, or 1% UV light at wavelengths between 250 and 400 nmor any sub-range there between; for example, between 250 and 300 nm, 300and 350 nm, or 350 and 400 nm.

In some embodiments, as shown in FIGS. 1A and 1B, a dressing 2 mayinclude an adhesive 8. The adhesive may function to couple, adhere,attach, or otherwise fasten a dressing to a patient's skin. In someembodiments, the adhesive 8 is positioned on a peripheral region of thedressing. For example, in some embodiments, the medicament 6 is borderedon one or more sides of its perimeter by the adhesive 8. In someembodiments, the dressing 2 is formed of a body layer 4, an adhesivelayer 8, and a medicament layer 6. In some such embodiments, theadhesive layer 8 and the medicament layer 6 are each coupled to a bottom(i.e., skin interfacing) surface of the body layer 4, and the adhesivelayer 8 is disposed around the medicament layer 6 (the medicament may bein a contacting or non-contacting arrangement with the adhesive). InFIG. 1B, the adhesive layer 8 circumscribes the medicament layer 6,forming an island region 3 within which the medicament is positioned. Insome embodiments, the medicament 6 is a layer having a diameter (D) orlength, width, thickness, and surface area. This surface area may beless than the surface area of the adhesive 8. In one embodiment, thedressing includes adhesive 8 at least on a peripheral region of thesupport body 4 configured to secure the support body 4 to a patient'sskin. In some embodiments, the adhesive 8 may be a thin film to improveconformation to a patient's body. In some embodiments, to improvecomfort, the dressing may include a thickness of less than 3, 2.5, 2,1.5, 1, 0.5, or 0.25 cm. In one embodiment, the dressing includes athickness of less than 0.5 cm. Thus, the medicament layer and adhesivelayer may have a thickness that is thinner than the overall thickness ofthe dressing.

A mentioned, in general a medicament may be formed of, or otherwiseincludes, a semisolid substance with a viscosity greater than water(i.e., greater than 8.90×10⁻³ dyns/cm² at about 25° C.). For example,the medicament may be formed of or include a hydrogel layer. Thehydrogel typically includes water at a concentration between 0.1% and99.9% or any sub-range there between, e.g., between about 10% and 99.9%,20% and 99.9%, 30% and 99.9%, 40%, and 99.9%, 50% and 99.9%, 60% and99.9%, 70% and 99.9%, 80% and 99.9%, 90% and 99.9%, 95% and 99.9%, or97% and 99.9%.

In some variations the medicament (e.g., hydrogel with therapeuticagent) may be used without a dressing, e.g., by itself. For example,FIG. 1C illustrates a hydrogel that may be used with a phototherapysystem. In this example, the hydrogel 7, includes coal tar (and/or coaltar extract) within the gel. This gel may be formed into a relativelythin layer (e.g., between about 0.1 inches to about 0.01 inches that isapplied to the skin. The hydrogel may be sufficiently adhesive (tacky)to be secured without the need for an additional adhesive, or anadditional adhesive material may be used (e.g., around the periphery).When used with a UV phototherapy light source, such as those descriedherein, it may be placed over the hydrogel (and in some cases againstthe hydrogel) or over the skin surrounding the hydrogel. In general, ahydrogel may include water in a concentration between 0.001% and 10%,10% and 20%, 20% and 30%, 30% and 40%, 40% and 50%, 50% and 60%, 60% and70%, 70% and 80%, 80% and 90%, or 90% and 99.9%.

As mentioned, the dressing may be configured to have a moisture vaportransmission rate of less than the skin or less than 2.5, 2.25, 2.0,1.75, or 1.5 g/m²/h (grams/meter²/hour). In one embodiment, the dressinghas a moisture vapor transmission rate of less than 2.4 g/m²/hour.Increased moisture levels may increase the transparency of the skin totherapeutic light and decrease the thickness of the epidermis, allowinglight to reach deeper and have an increased therapeutic effect. Althoughany of the dressing described herein may be configured to include amaterial (and/or coating, layer, etc.) that has a low moisturetransmission rate, such an additional component may not be necessary,particularly when the dressing includes a hydrogel having a relativelylarge percentage of water.

In some embodiments, the dressing may increase the local temperature andreduce the proliferation of skin cells under the dressing. The dressingmay function as an insulating layer, or the dressing may include anincreased thickness for improved insulation. In some embodiments, thedressing may include a thermal conductivity of less than skin or lessthan 0.50, 0.40, 0.35, 0.30, 0.25, or 0.20 W/m/′ C. In one embodiment,the dressing may include a thermal conductivity of less than 0.32 W/m/′C.

A dressings may have any appropriate shape, for example a triangle,rectangle, square, circle, or hexagon, for enabling full coverage of anylesion size or shape. The dressing may be any appropriate size. Forexample the dressing may have a (planar) width or diameter dimension,referred to herein as a diameter D and depicted in FIG. 1B, of less than20, 15, 10, 5, 4, 3, or 2 inches to minimize the amount of unaffectedskin that is treated. By minimizing the dimensions of the dressing, thedressing may cover a minimum amount of healthy skin. Alternatively, forlarger lesions, multiple dressings may be positioned on the skinadjacent to each other. The dressing may be marked or printed, includingfiduciary markers for alignment with a UV light source, and may alsoinclude one or more identifiers, as described below.

In some embodiments, an outer edge of the body of the dressing(excluding the thin adhesive film border) may have the same dimension asan inner edge of a UV light source (described in more detail below),such that accidental detachment due to shear force may be reduced.Further, in some embodiments, the outer edge of the body of the dressingmay be thin, compared to more centrally located regions (even on theperipheral region), reducing risk of accidental failure from shearforces.

As mentioned, and of the variations described herein may include one ormore identifiers, including unique identifiers. FIGS. 2A-2D illustratefour embodiments of unique identifiers 10 of a dressing 2. A uniqueidentifier may be correlated with one or more of: dressing type, numberof uses (e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, greater than 10),manufacturer, purchase date, serial number, indication, prescription,patient name, dressing absorption of UV light, or any other informationrelevant to the dressing, patient, or indication. The unique identifierrefers to the ability of the identifier to correlate information with aparticular dressing on a particular patient. The dressing identifier maybe made unique when associated with the particular location it isapplied on a particular patient.

A unique identifier 10 may be designed, sized, and positioned tominimize blocking of therapeutic light. For example, a unique identifiermay be completely transparent to therapeutic light or may be located ona dressing on the periphery of the outside of the dressing orsubstantially outside of the body of the dressing where therapeuticlight is directed (e.g., FIG. 2B). In some embodiments, a uniqueidentifier may include RFID (e.g., FIG. 2C), a near field communication(NFC) chip (e.g., FIG. 2C), an optical code (e.g., q-code; FIG. 2D), auniversal product code (UPC) (e.g., FIG. 2D), a magnet with a uniquemagnetic field (e.g., FIG. 2A), an infrared (IR) reflective strip (e.g.,FIG. 2B), a giant magnetoresistance, or any other identifier known toone skilled in the art. In one embodiment, the unique identifier 10includes a magnet or series of magnets configured to induce a specificmagnetic field based on a ferromagnetic material coupled to the magnetor series of magnets, as shown in FIG. 2A. For example, theferromagnetic material coupled to the magnet may include stainlesssteal, iron, nickel, cobalt, neodymium, samarium-cobalt magnets, or anyother ferromagnetic material. In some embodiments, the magnets may bepositioned as far away from the center of the dressing and/or each otheras possible to minimize moments and accidental disconnection of thelight from the dressing, for example from shear, peeling, and/or pullforces.

In some embodiments, the dressing may include multiple uniqueidentifiers that, when combined, create a unique code for each dressing.For example, the presence or absence of multiple magnets detectable by aHall Effect sensor or reed switch on the light (described below) couldform a binary code that is used to create an identifying code for adressing. This code may then be used to recognize a dressing duringtherapeutic use. For example, a device, such as the light sourcedescribed below, may be configured to read the code when it is initiallycoupled to the dressing and store the code for subsequent uses of thedressing.

A unique identifier may be read by a device. For example, the uniqueidentifier may be read by a mobile device, handheld device (e.g.,smartphone), scanner, computing device, light source (e.g., UV lightsource), or any other type of device capable and configured to read it,e.g., having a reed switch, Hall Effect sensor, or any other type ofswitch or sensor. In one embodiment, the unique identifier may be readby a handheld light source, for example a UV light source, comprising aHall Effect sensor, as will be described in further detail below. Theidentifier may be encoded (e.g., to protect patient privacy), so thatonly approved (e.g., paired) devices are able to read the informationencoded.

One or more dressing may be included in a kit with multiple dressings;in some variations, each dressing includes a unique identifier. In somevariations, each dressing may include the same identifier or a differentidentifier. Each dressing in a kit may include a different medicamentand be configured to be delivered in a multi-step process. For example,the first dressing may descale, the second dressing may be configured todecrease cellular product, the third dressing may be configured tophotosensitize the skin, and the fourth dressing may be configured toincrease penetration.

As mentioned above, a medicament may include any appropriate therapeuticagent, including (but not limited to) one or more of: coal tar, coal tarextract, corticosteroids, salicylic acid, anthralin (dithranol), cadeoil, vitamin D analogues (e.g., calcipotriene, anthralin, tazarotene,calcitriol), steroids, psoralen, aloe vera, jojoba, zinc pyrithione,capsaicin, acetic acid, urea, phenol, or any other medicament known toone skilled in the art. In the context of the medicaments and dressingsdescribed herein, these agents do not significantly occlude UV lightwhen included in the dressing.

A kit may include one or more reusable dressings as well as one or morethin films with waterproof adhesives for re-attaching the dressing tothe skin.

As described in greater detail below, and of the dressing describedherein may include a connector configured to connect (e.g.,specifically, securely and releasably connect) to an energy applicatorsuch as a phototherapy UV light source. The connector may be mechanical,electromagnetic, chemical, or the like, and may be located anywhere onthe dressing, including in particular, regions peripheral to the regionover the medicament when applied to a patient's body.

Any of the medicaments and/or dressing described herein may be used aspart of a system including an energy applicator, such as a phototherapyUV light source. For example, FIGS. 3A-3C illustrate three embodimentsof systems for treating skin disorders or other health conditions byultraviolet phototherapy. A system for treating skin disorders or otherconditions by UV phototherapy may include a dressing 2, a UV lightsource 12, and control logic (e.g., operating a general or dedicatedprocessor and configured to control a computing device 28 and/or lightsource 12). The dressing 2 may be adapted to occlude less than athreshold level of UV light (e.g., 50% of UV light at wavelengthsbetween 250 and 400 nm, e.g., between 300 and 320 nm), as describedabove. In some embodiments, the dressing may include a first connector14 a. The system may include a UV light source 12 configured to emit UVlight at an intensity of greater than 2 mW/cm² at a wavelength between300 and 320 nm. Further, the UV light source 12 may include a secondconnector 14 b configured to couple to the first connector 14 a on thebody. The system may additionally or alternatively include a controllogic configured to determine a treatment dose, and in variousembodiments, the control logic controls application of the treatmentdose by the UV light source 12. As mentioned above, a hydrogel insteadof a dressing may be used with a phototherapy system. A hydrogel mayinclude water in a concentration between 0.001% and 10%, 10% and 20%,20% and 30%, 30% and 40%, 40% and 50%, 50% and 60%, 60% and 70%, 70% and80%, 80% and 90%, or 90% and 99.9%.

In some embodiments, a system for treating skin disorders by UVphototherapy functions to deliver UV light to a portion of skin that isaffected by a skin disorder, for example psoriasis, but alternatively,the system may be used in any suitable application, clinical orotherwise.

Also described herein are phototherapy UV light sources. In general, aphototherapy UV light source include one or more UV light emitter (e.g.,LED, CFL, etc.) that is configured to emit (and in some casesspecifically emit) UV light in the target wavelength range (e.g.,300-320 nm, etc.). The phototherapy device may also include a powersource (e.g., battery, long-lasting capacitor, etc.), a controller(e.g., circuitry connected to the power source and UV light emitter tocontrol operation of the device), which may include one or moreclock/timer and a communications circuit (e.g., wireless communicationcircuit, such as Bluetooth, WiFi, ultrasound, etc.). The UV light sourcemay also include a protective shroud or cover for mating with thepatient's skin and/or the dressing. The UV light source may also includeone or more connectors for coupling with the dressing as describedherein. In some variations the UV light source also includes a readerfor reading an identifier on a dressing. A UV light source may alsoinclude one or more indicators (including non-UV light emitters) toindicate when the device is in operation (e.g., when the UV light ison); the indicator may be visible on an outer surface of thephototherapy UV light source device and/or it may shine light with theUV light (e.g., into a shroud or cover region), so that the user canvisually identify when the UV light is on. Any of these devices may alsoinclude safety circuitry and/or logic configured to disable the emissionof UV light when not connected to the patient and/or a dressing.

As shown in FIGS. 3A and 3B, a system for treating skin disorders orother health conditions by ultraviolet phototherapy may include aphototherapy UV light source 12 (also referred to as a simply a UV lightsource). The UV light source 12 functions to couple to the dressing 2and to deliver UV light through the dressing to a target, such as a skinlesion 30, on a patient. In some embodiments, the light source 12 mayinclude a light emitting diode (LED), a compact fluorescent lamp (CFL),an arc lamp, or any other type of light source. In one embodiment, thelight source includes one or more LEDs 26. In some embodiments, the UVlight source is configured to emit UV light at an intensity of greaterthan 1, 2, 2.5, 3, or 3.5 mW/cm². In some embodiments, the UV lightsource is configured to emit UV light at a wavelength between 300 and320 nm. In one embodiment, the UV light source emits UV light at anintensity of greater than 2 mW/cm² at a wavelength between 300 and 320nm. In some embodiments, the UV light source emits UV light at awavelength between 250 and 400 nm or any sub-range there between, suchas 250 and 300 nm, 300 and 350 nm, or 350 and 400 nm. In one embodiment,the UV light source emits UV light at a wavelength between 300 and 320nm.

As shown in FIGS. 3A and 3B, the UV light source may include a battery16 (and/or a port or other connection to a secondary device, forexample, a mobile device for power), a controller 18 which may include amicroprocessor and memory (e.g., ASIC) with the control logic storedthereon, a Bluetooth antenna or other wireless technology (e.g.,infrared or near-field communication beacon) 20 or a hard-wiredconnection (e.g., FireWire IEEE 1394, universal serial bus) forcommunicating with a separate and/or second controller 28, such as amobile device, a sensor 24 for reading one or more unique identifiers,and/or a shield 22 for increasing focus of the UV light to the dressingand reducing exposure of unintended areas to the UV light. In someembodiments, the control logic of the UV light source determines andcontrols the settings and functionality of the light. In otherembodiments, the separate controller 28, additionally or alternativelydetermines and controls the function of the light. The wirelesscommunication may be done with near infrared, Wi-Fi, or Bluetooth.Additionally or alternatively, as shown in FIG. 3B, the light source mayinclude a camera 38 for identifying the edges of the lesion, in order tofacilitate proper positioning of the dressing and/or light source overthe lesion.

In some embodiments, the controller may vary the initial UV lightadministered to different lesions to more quickly determine a minimalerythemal dose (MED) for different parts of the body and/or to determinean ideal MED for the patient. In some embodiments, the MED may bedetermined based on feedback from the patient. Additionally oralternatively, a controller may provide multiple doses in a day, suchthat an MED is not exceeded and/or the patient does not experienceredness, burning, itching, or induration.

Any of the apparatuses described herein may also include control logicfor controlling the application of energy and/or for determining atherapeutic dose, therapeutic regimen and/or for monitoring theapplication of the therapy. The control logic may generally be hardware,software, firmware, or some combination thereof. For example, in someembodiments, a mobile device 28 in communication with the light source12 may include an application (“app”) that configures the mobile device(e.g., smartphone) to operate as the control (e.g., running the controllogic). In such embodiments, the mobile device 28 may include aprocessor and memory with instructions for the app's graphical userinterface stored thereon. The memory may further include additionalinstructions for interacting with the controller and for processing datareceived from the controller 18. In various embodiments, both the mobiledevice 28 and the controller 18 include a wired or wireless connectionto enable two-way communication between the devices. In at least someembodiments, the mobile device 28 is also in wireless communication witha remote application server, which stores additional instructions and/ordatabases and is configured to transmit data to, and receive data from,the mobile device 28. In various embodiments, biographical informationabout a user (i.e., user profile information) and data about past use(e.g., data and time of application, treatment dosage applied, anddocumented photographs) are stored within the server.

In some embodiments, the app may allow the patient to input informationto determine his/her Fitzpatrick skin type and use this information totailor the initial dose of light to the patient. Fitzpatrick skin typeis determined by answering a series of validated questions about eyecolor, hair color, skin color, freckles, and/or skinreaction/sensitivity to sun and sun exposure. The app may remind thepatient to deliver the therapy on a regular basis and display a visualimage or chart of the amount of energy delivered to each lesion. Apatient may use the phone camera through the app to identify a lesion onthe patient's skin and to record where the lesion is on his/her body andtrack progression of the lesion. Further, a patient may use the phonecamera through the app to take a picture of a temperature and/or UVlight sensitive color-changing strip to determine the amount of energyto deliver to the patient's skin to avoid damage. The app may take apicture of the lesion during therapy and then display images of eachlesion over time to the patient or post to a social network (e.g., topenalize patients for missing an application, reward patients fordelivering an application, allow patients to share success stories andtips for usage).

The UV light source 12 may couple to a dressing 2 and/or to the patient.For example a UV light source may couple to the patient and/or dressingusing one or more of: a strap that wraps around the patient's body, are-usable pressure sensitive adhesive, single use adhesive strips, oneor more magnets, one or more electromagnetics, one or more ferromagneticmaterials, sub-atmospheric pressure (e.g., generated from a suctionunit), a mechanical connection (e.g., snaps, Velcro, zipper, buttons),or any other coupling mechanism. In one embodiment, as shown in FIG. 3A,the light source includes a second connector 14 b comprising, forexample a magnet, for coupling to a first connector 14 a, for example amagnet, on the dressing 2. Additionally or alternatively, as shown inFIG. 3C, the second connector 14 b on the light source 12 may be securedto the light source by a holder 15. The holder 15 may include at leastone wall, such that the holder 15 surrounds and secures the secondconnector 14 b to the light source. In some embodiments, a plurality ofwalls substantially surrounds the second connector 14 b on all sides. Atleast one of said walls may include an aperture 17. The aperture 17 inthe wall of the holder 15 may be sized and configured for receiving thefirst connector 14 a (located on the dressing), such that the first andsecond connectors are in direct contact to maximize an attraction, forexample magnetic attraction, and/or a contact surface area between thefirst and second connectors. The light source 12 may detect the couplingof the light source to the dressing or the proximity of the light sourceto the dressing. In some embodiments, the detection of the couplingbetween the dressing and the light source triggers a safety circuit thatallows for therapeutic light to be delivered only when attachment orproximity to the dressing is detected.

Further, the light source 12 may optionally include an apron, shield, orsafeguard 22 to reduce or prevent accidental use of the light and/orexposure of tissue that is not under a dressing. In some embodiments,the apron, shield, or safeguard 22 may include smart glass or switchableglass, such that it blocks the UV light from reaching the healthy skin.Further, the shield 22 may include a compressible and/or displaceablesection or portion, such that the shield may conform to curved surfacesof the body. The compressible portion may include a reticulated opencell foam with multiple layers of varying stiffness. Alternatively, thecompressible portion may include a displaceable low durometer siliconethat is UV transparent. In some embodiments, the curved surface of thebody may be detected by the shield, for example using a 3D scan of thebody surface. Further, in some embodiments, the shield 22 may beconfigured to focus light across an aperture plane. For example, thelight shield may include a high efficiency diffuse reflector orelliptical shape to distribute light equally across the aperture planeor have a non-continuous shape to fit within an external structure.

Any of the systems for treating skin disorders by UV phototherapydescribed herein may include control logic. In some variations thecontrol logic determines a treatment dose and/or regimen of UV lightbased on one or more of: disease type, a skin type, a patient feedbackon a sensitivity of a lesion or group of lesions, a previous dosehistory, an amount of UV light absorbed by the dressing, an edgedetection for recognition and guidance of the UV light, an amount ofinduration, an amount of scale, an amount of redness, a location of thelesion, and/or a thickness of the epidermis, as shown in FIG. 6.Further, the control logic may (in some variations) control theapplication of the determined dose by the UV light source. For example,the light source may deliver a narrowband of UV light at a wavelengthbetween 300 and 320 nm, and in some embodiments, the closer thewavelength gets to 300 nm, the smaller the half power full width powerwill be to minimize the amount of light below 300 nm which is nottherapeutically effective. Further, the closer the wavelength gets to300 nm, the more the dose of light may be decreased. For example, insome embodiments, the dose of UV light determined by the control logicdepends on the center of the light wavelength. As one example, awavelength with a center or average at 310 nm induces the maximum dose,while a wavelength of 304 nm or any wavelength less than 304 nm inducesa dose of less than half the dose given at 310 nm. In some embodiments,the center of the light wavelength is held at a value or varied betweena plurality of values each greater than 296 nm. As another example, awavelength with a center or average of less than 306 nm has a full widthhalf power of less than 30 nm and a treatment dose of less than 130mj/cm², where 130 mj/cm² is based on an MED recommended minimum dose fornarrowband UVB light treatment by the American Academy of Dermatology.

A system for treating skin disorders by UV phototherapy may include adressing labeling system. The dressing labeling system may function todifferentiate different parts of the body or other use specifications,such that each label may be read by a light source and indicate, forexample a location, indication, date, number of uses, and/or any otherinformation. By grouping the dressing by region of the body, the dosingfor a region of the body can be grouped to simplify the number ofidentifiers needed for the body. For example, if the body may be dividedinto three regions: trunk, above elbows and knees, and below elbows andknees, a person who has multiple lesions on different parts of theirbody may only need three types of dressing and may only need to enter insensitivity to previous days' treatment one time. Alternatively, thebody could be divided into 5 regions: trunk to knees and elbows, knees,below knees, elbows, and beyond elbows.

FIGS. 4A-4C illustrate two embodiments of a dressing 2 with connectors14 for alignment with a light source 12. As shown in FIGS. 4A-4C, adressing 2 may include one or more connectors 14 for coupling andaligning with a light source 12. In some embodiments, the connectors 14in the dressing 2 may include one or more magnets. For example, themagnets may include neodymium, iron boron (e.g., NDFeB, NIB), samariancobalt (SmCo), electromagnets, or ferromagnets. In some embodiments, asshown in FIG. 4A, the connectors of the dressing 2 and light source 12may be misaligned in a first configuration to limit connectivity andinhibit delivery of therapeutic light; in a second, rotatedconfiguration, the pattern of the connectors on the light source mayalign with the corners of the body of the dressing, as shown in FIG. 4B.In such embodiments, the dressing 2 and light source 12 may berestricted to one or two orientations of 180 degrees rotation relativeto each other if the dressing is a rectangle. Alternatively, if thedressing is a square, the magnets may enable four orientations of 90degrees of rotation relative to each other. In some embodiments, theconnectors may be square, rectangle, circle, oval, diamond, hexagon,triangle, or any other shape. Alternatively or additionally, theconnector may include a first dimension longer than a second dimensionto force alignment between the dressing and the light source, forexample if the connector 14 is positioned in the middle of the body ofthe dressing 2 or light source, as shown in the embodiment of FIG. 4C.

FIG. 5 illustrates one embodiment of a system with a safety (e.g.,shutdown circuit 32). The shutdown circuit 32 may function to disengagethe dressing 2 from the light source 12 or turn off the light sourceduring adverse or harmful events. For example, the shutdown circuit 32may turn off some of or all the lights of the light source to preventoverheating or heating beyond a certain amount determined by thephysical limits of proper function of the light source or to preventdamage to the skin of the patient. In some embodiments, the shutdowncircuit 32 may directly measure the light source temperature with athermistor or with a control circuit that is preprogrammed to limit theuse time of one or more of the LEDs. Further, temperature limitations onthe circuit may ensure that the LEDs maintain their specifiedwavelengths. Further, in some embodiments, the dressing may include acolor changing temperature sensitive strip to indicate a temperature ofthe dressing.

FIG. 7 illustrates a location indexing system 34 for a person's hand(s)and/or foot/feet 36. A location indexing system functions to providelocation indexing of the tips of the fingers or toes for easy repeateddosing of light to a lesion on the hands or feet. This system could beuseful in directing light to the same spot on the hands or feet each daywithout having to wear gloves or small dressings around the smalldimensions of the toes and fingers. Further, a location indexing systemmay be form fitting like a glove or be indexed by the tips of the feetand toes, such that the extremity is fully inserted to allow properdirecting of light. The locating system may be made of a material thatis transparent to ultraviolet light and fits various sizes ofhands/feet. The indexing system may be a grid pattern on a flat surfaceto easily locate the light on a specific hand/foot location, as shown inFIG. 7. It may have connectors that allow for easy attachment of a lightsource. The connectors could be magnetic or ferromagnetic for example.

In some embodiments, a system for treating skin disorders by UVphototherapy may include a telehealth light therapy system. Thetelehealth light therapy system may function to optimize the amount oflight delivered to a lesion and minimize the amount of light deliveredto healthy skin. In one embodiment, a telehealth system may include oneor more digital cameras; software for edge detection of lesion andidentifying induration, redness and scale of a lesion; softwareconfigured to adjust the treatment dose and light beam size and shapebased on lesion edge, lesion characteristics (e.g., induration, rednessand scale), previous dose history, skin type, and/or patient feedback onskin sensitivity; a UV light source capable of changing the size andshape of the light beam; and contact sensor for ensuring a specificdistance between a patient's skin and the light source. In someembodiments, the telehealth system may be installed into a stand-aloneteleheath unit and be connected to a computer via a USB connection.Alternatively, the telehealth system may be connected to the lightsource, a mobile device in communication with the light source, or anyother computing device. In some embodiments, the telehealth system maybe configured to calculate a lesion's healing progress based on redness,scale, and induration. In some embodiments, a remote doctor may monitorthe progress of the patient's lesions after treatment using thetelehealth system.

Methods

Any of the apparatuses described herein may be used to treat a patientfor a disorder, such as a skin disorder. For example, the dressingsand/or phototherapy UV light sources described herein may be used totreat a patient for a skin disorders such as psoriasis.

In general, a method of treating a patient may include applying amedicament to the patient (e.g., applying the hydrogel and agent such ascoal tar, as described above, so that the medicament occludes less thana target percentage, e.g., 50%, of UV light in the therapeuticwavelength range, e.g., 300-320 nm), and then applying UV light. Forexample, the medicament may be applied using a dressing, e.g., themedicament may be incorporated into the dressing, and UV light may beapplied through the medicament (and any intervening region of thedressing) at a desired dose (e.g., light intensity and duration).Multiple locations may be treated sequentially or simultaneously on thepatient's body. The dosage and/or treating regimen (e.g., number andtiming of therapeutic doses) may be determined before or duringtreatment. Multiple doses may be applied during the same day. Ingeneral, dosing with UV may be concurrent with the delivery oftherapeutic agent (e.g., coal tar and/or coal tar extract) from thedressing.

FIG. 8 illustrates one example of a method for treating psoriasis by UVphototherapy. In this embodiment, the method includes attaching adressing to a patient over a skin lesion, such that the dressing createsa thermally-insulating, moisture-occlusive barrier, and the dressingused is configured to occludes less than a target percent (e.g., 50%) ofUV light at wavelengths in a therapeutic range (e.g., between 300 and320 nm) S100. The UV light source may be coupled to the dressing S110.The UV light source may be configured as described above, to provide UVlight at a dose (light intensity and duration), and may include any ofthe features described above, including interlock/confirmation ofcontact with the patient and/or dressing, etc. For example, the UV lightsource may communicate with the dressing and/or with a remote processorsuch as a smartphone or other device operating control logic. Thus, insome variations a handheld device may read an identifier on thedressing. The handheld device may confirm the timing of the dose (e.g.,indicating, to a user, to attach the UV light source to thedressing/patient) and/or may calculate a treatment dose of UV lightS120. The handheld device may then automatically apply the calculatedtreatment dose of UV light through the dressing attached to the patientS130. In some variations a separate handheld device is not necessary,and the dosage may be manually selected for the UV light source.Alternatively the UV light source may assume the functions of thehandheld device described herein, such as calculating the dose and/orreading an identifier on the dressing.

Thus, described herein are methods to treat a skin lesion (e.g.,psoriasis) on a patient using a dressing coupled to a therapeutic lightsource, for example a UV light source. Alternatively, the methods may beused in any wound healing or light therapy application, clinical orotherwise.

As shown in FIG. 8, one embodiment of a method for treating psoriasis byUV phototherapy includes attaching a dressing to a patient over a skinlesion, such that the dressing creates a thermally-insulating,moisture-occlusive barrier, and the dressing occludes less than 50% ofUV light at wavelengths between 300 and 320 nm S100. In some variationsthe method includes a two step process including applying a medicament,for example a viscous coal tar gel, or the hydrogel with coal tar, to askin region and then positioning a dressing over the medicament. Any ofthe dressings described herein do not need to be thermally-insulating ormoisture-occlusive, but these optional features may be beneficial. Insome embodiments, the dressing occludes little to no UV light, such thatsubstantially all UV light may pass through the dressing. The dressingmay be sized and configured to cover only the skin lesion, such thatadjacent skin areas not requiring light therapy are excluded from thearea covered by the dressing. In some embodiments, two or more dressingsmay be positioned adjacent to one another to achieve a larger treatmentarea.

A method for treating psoriasis by UV phototherapy may include couplinga UV light source to the dressing S110, which may be performed before,after or during calculation of the dose. The UV light source may bealigned and coupled with the dressing to permit UV light treatment of askin lesion while reducing or preventing UV light treatment of healthyskin adjacent to the skin lesion. Coupling and alignment may beperformed as described above. For example, in one embodiment, a firstconnector on the dressing, for example a magnet, aligns and couples thedressing with a light source including a second connector, for example amagnet.

As shown in FIG. 8, a method for treating psoriasis by UV phototherapymay include reading (e.g., using a handheld device) a unique identifieron the dressing, wherein upon reading the unique identifier, thehandheld device calculates a treatment dose of UV light S100. In someembodiments, a handheld device is a light source (e.g., UV lightsource), a mobile device, a scanner, or any other computing device. Inone embodiment, the handheld device includes a UV light source. In someembodiments, the handheld device may use one or more parameters tocalculate the treatment dose of UV light. For example, the calculationmay be based on a type of disease, a skin type, a patient feedback on asensitivity of a lesion or group of lesions, a previous dose history, anamount of UV light absorbed by the dressing, an edge detection forrecognition and guidance of the UV light, an amount of induration, anamount of scale, an amount of redness, a location of the lesion, anamount of UV light absorbed by the dressing, and/or the thickness of theepidermis. The calculation may include algorithms based on publishedguidelines for therapeutic light treatment of specific conditions likepsoriasis, for example the American Academy of Dermatology's algorithmfor narrowband ultraviolet B light from “Guidelines of care for themanagement of psoriasis and psoriatic arthritis, Section 5. Guidelinesof care for the treatment of psoriasis with phototherapy andphotochemotherapy.”

As shown in FIG. 8, a method of treating psoriasis by UV phototherapymay include automatically applying the calculated treatment dose of UVlight through the dressing attached to the patient S130. In someembodiments, the light source may detect a coupling between the lightsource and the dressing, and in some embodiments, the light source mayautomatically apply the UV phototherapy only once the connection isdetected. Alternatively, a user may be prompted to initiate aphototherapy session once the light source detects a connection to thedressing. In some embodiments, a user may override or adjust thecalculated treatment dose based on one or more parameters, for example aprescription from a physician.

The systems and methods of the preferred embodiment and variationsthereof can be embodied and/or implemented at least in part as or by amachine configured to receive a computer-readable medium storingcomputer-readable instructions. The instructions are preferably executedby computer-executable components preferably integrated with the systemand one or more portions of the processor and/or the controller. Thecomputer-readable medium can be stored on any suitable computer-readablemedia such as RAMs, ROMs, flash memory, EEPROMs, optical devices (e.g.,CD or DVD), hard drives, floppy drives, or any suitable device. Thecomputer-executable component is preferably a general orapplication-specific processor, but any suitable dedicated hardware orhardware/firmware combination can alternatively or additionally executethe instructions.

When a feature or element is herein referred to as being “on” anotherfeature or element, it can be directly on the other feature or elementor intervening features and/or elements may also be present. Incontrast, when a feature or element is referred to as being “directlyon” another feature or element, there are no intervening features orelements present. It will also be understood that, when a feature orelement is referred to as being “connected”, “attached” or “coupled” toanother feature or element, it can be directly connected, attached orcoupled to the other feature or element or intervening features orelements may be present. In contrast, when a feature or element isreferred to as being “directly connected”, “directly attached” or“directly coupled” to another feature or element, there are nointervening features or elements present. Although described or shownwith respect to one embodiment, the features and elements so describedor shown can apply to other embodiments. It will also be appreciated bythose of skill in the art that references to a structure or feature thatis disposed “adjacent” another feature may have portions that overlap orunderlie the adjacent feature.

Terminology used herein is for the purpose of describing particularembodiments only and is not intended to be limiting of the invention.For example, as used herein, the singular forms “a”, “an” and “the” areintended to include the plural forms as well, unless the context clearlyindicates otherwise. It will be further understood that the terms“comprises” and/or “comprising,” when used in this specification,specify the presence of stated features, steps, operations, elements,and/or components, but do not preclude the presence or addition of oneor more other features, steps, operations, elements, components, and/orgroups thereof. As used herein, the term “and/or” includes any and allcombinations of one or more of the associated listed items and may beabbreviated as “/”.

Spatially relative terms, such as “under”, “below”, “lower”, “over”,“upper” and the like, may be used herein for ease of description todescribe one element or feature's relationship to another element(s) orfeature(s) as illustrated in the figures. It will be understood that thespatially relative terms are intended to encompass differentorientations of the device in use or operation in addition to theorientation depicted in the figures. For example, if a device in thefigures is inverted, elements described as “under” or “beneath” otherelements or features would then be oriented “over” the other elements orfeatures. Thus, the exemplary term “under” can encompass both anorientation of over and under. The device may be otherwise oriented(rotated 90 degrees or at other orientations) and the spatially relativedescriptors used herein interpreted accordingly. Similarly, the terms“upwardly”, “downwardly”, “vertical”, “horizontal” and the like are usedherein for the purpose of explanation only unless specifically indicatedotherwise.

Although the terms “first” and “second” may be used herein to describevarious features/elements (including steps), these features/elementsshould not be limited by these terms, unless the context indicatesotherwise. These terms may be used to distinguish one feature/elementfrom another feature/element. Thus, a first feature/element discussedbelow could be termed a second feature/element, and similarly, a secondfeature/element discussed below could be termed a first feature/elementwithout departing from the teachings of the present invention.

As used herein in the specification and claims, including as used in theexamples and unless otherwise expressly specified, all numbers may beread as if prefaced by the word “about” or “approximately,” even if theterm does not expressly appear. The phrase “about” or “approximately”may be used when describing magnitude and/or position to indicate thatthe value and/or position described is within a reasonable expectedrange of values and/or positions. For example, a numeric value may havea value that is +/−0.1% of the stated value (or range of values), +/−1%of the stated value (or range of values), +/−2% of the stated value (orrange of values), +/−5% of the stated value (or range of values), +/−10%of the stated value (or range of values), etc. Any numerical rangerecited herein is intended to include all sub-ranges subsumed therein.

Although various illustrative embodiments are described above, any of anumber of changes may be made to various embodiments without departingfrom the scope of the invention as described by the claims. For example,the order in which various described method steps are performed mayoften be changed in alternative embodiments, and in other alternativeembodiments one or more method steps may be skipped altogether. Optionalfeatures of various device and system embodiments may be included insome embodiments and not in others. Therefore, the foregoing descriptionis provided primarily for exemplary purposes and should not beinterpreted to limit the scope of the invention as it is set forth inthe claims.

The examples and illustrations included herein show, by way ofillustration and not of limitation, specific embodiments in which thesubject matter may be practiced. As mentioned, other embodiments may beutilized and derived there from, such that structural and logicalsubstitutions and changes may be made without departing from the scopeof this disclosure. Such embodiments of the inventive subject matter maybe referred to herein individually or collectively by the term“invention” merely for convenience and without intending to voluntarilylimit the scope of this application to any single invention or inventiveconcept, if more than one is, in fact, disclosed. Thus, althoughspecific embodiments have been illustrated and described herein, anyarrangement calculated to achieve the same purpose may be substitutedfor the specific embodiments shown. This disclosure is intended to coverany and all adaptations or variations of various embodiments.Combinations of the above embodiments, and other embodiments notspecifically described herein, will be apparent to those of skill in theart upon reviewing the above description.

What is claimed is:
 1. A phototherapy dressing for treating psoriasis,the dressing comprising: a support body; a medicament in communicationwith the support body, the medicament comprising a hydrogel including asuspension of between 0.1% and 5% (by weight/volume) coal tar or coaltar extract mixed in the hydrogel, wherein the hydrogel comprisesgreater than 90% water and is between 0.005 to 0.1 inches thick; whereinthe medicament and support body together occlude less than 80% of UVlight at wavelengths between 300 and 320 nm from passing through thephototherapy dressing; an adhesive on the phototherapy dressing; and anattachment for a phototherapy UV light source on the support body, theattachment configured to secure the phototherapy UV light source overthe medicament.